FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446844235
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
804-06-400
Device description
AltiVate Reverse Glenoid Hood Rasp Guide Inserter
Published
2024-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWBEXTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446844235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446844235001904468442351904468442350190446844235

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
154074504
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888912024983DJO SURGICAL520-38-0142017-08-07
00888912024990DJO SURGICAL520-38-0182017-08-07
00888912025003DJO SURGICAL520-38-1182017-08-07
00888912025010DJO SURGICAL520-42-0202017-08-07
00888912025027DJO SURGICAL520-42-1162017-08-07
00888912025034DJO SURGICAL520-46-1162017-08-07
00888912025041DJO SURGICAL520-46-1202017-08-07
00888912025058DJO SURGICAL520-50-1182017-08-07
00888912025065DJO SURGICAL520-50-1222017-08-07
00888912025072DJO SURGICAL520-50-1262017-08-07
00888912025089DJO SURGICAL520-54-1182017-08-07
00888912145114DJO SURGICAL520-42-0162017-08-07
00888912145138DJO SURGICAL520-42-1202017-08-07
00888912145145DJO SURGICAL520-46-0162017-08-07
00888912145152DJO SURGICAL520-46-0202017-08-07
00888912145169DJO SURGICAL520-46-0242017-08-07
00888912145190DJO SURGICAL520-46-1242017-08-07
00888912145206DJO SURGICAL520-50-0182017-08-07
00888912145213DJO SURGICAL520-50-0222017-08-07
00888912145220DJO SURGICAL520-50-0262017-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295543695ATTUNEDEPUY (IRELAND)HWB2025-10-31
00818069011031TecometTECOMET INC.HWB2023-08-10
00818069011048TecometTECOMET INC.HWB2023-08-10
00818069011055TecometTECOMET INC.HWB2023-08-10
00818069011062TecometTECOMET INC.HWB2023-08-10
00818069011079TecometTECOMET INC.HWB2023-08-10
00818069011086TecometTECOMET INC.HWB2023-08-10
00818069011093TecometTECOMET INC.HWB2023-08-10
00818069011109TecometTECOMET INC.HWB2023-08-10
00818069011116TecometTECOMET INC.HWB2023-08-10
00841435120365TecometTECOMET INC.HWB2022-10-03
00841435111226TecometTECOMET INC.HWB2020-10-09
00818069014858TecometTECOMET INC.HWB2020-10-09
00841435100688TecometTECOMET INC.HWB2020-10-09
00841435100695TecometTECOMET INC.HWB2020-10-09
00818069014339TecometTECOMET INC.HWB2020-08-20
00818069014346TecometTECOMET INC.HWB2020-08-20
00818069014353TecometTECOMET INC.HWB2020-08-20
00818069014360TecometTECOMET INC.HWB2020-08-07
00818069014377TecometTECOMET INC.HWB2020-08-07
00818069014384TecometTECOMET INC.HWB2020-08-07
00818069014391TecometTECOMET INC.HWB2020-08-07
00818069014407TecometTECOMET INC.HWB2020-08-07
00818069014414TecometTECOMET INC.HWB2020-08-07
10705034535364NADEPUY SPINE, LLCHWB2019-02-12
10705034535821NADEPUY SPINE, LLCHWB2019-02-12
10705034533650NADEPUY SPINE, LLCHWB2019-01-16
10705034533667NADEPUY SPINE, LLCHWB2019-01-16
10705034533674NADEPUY SPINE, LLCHWB2019-01-16
10705034533681NADEPUY SPINE, LLCHWB2019-01-16